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SDTMIG 3.4

  •  Resolve IS and PK JIRA Issues
  •  Insert statement on when NHOID should be used in examples 6-9 (waiting for Jon N review)

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Tests that are measuring and quantifying a subject's innate cellular and humoral immune responses to a microorganism or a vaccination agent, such as measurements of activated cytokine- or antibody –secreting cells, or cytokine response assays (i.e. interferon gamma response test), are biological measurements about the human subject. They are not assessments about the microorganism itself, hence NHOID should not be used in these cases.

SDTMIG 4.0

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